SOMA Genomics

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules Problem / Challenge Current EU regulatory frameworks treat targeted oncological therapies and their companion diagnostics as two separate products, converging only late in development. This fragmentation creates inefficiencies: duplicated assessments, delays, and increased costs.

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules - Incentives for CDx in Rare and Paediatric Cancers Problem / Challenge Targeted therapies for rare and paediatric cancers benefit from dedicated EU incentives: Regulation (EC) 141/2000 (Orphan Medicines) protocol assistance, reduced/waived fees, centralised procedure, and up to 10-year market exclusivity.

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules Guidance for CDx Development Problem / Challenge Many companion diagnostics (CDx), like many innovative targeted therapies, are initially developed by small and medium-sized enterprises (SMEs).

The proposed European Biotech Act rightly places strong emphasis on accelerating clinical development, improving regulatory efficiency, and strengthening Europes competitiveness in biotechnology. One additional consideration may merit greater attention during the legislative process: the role of patient identification in determining the success of biotechnology innovation.

Feedback on the proposed European Biotech Act The proposed European Biotech Act addresses key barriers that limit the EUs ability to translate strong life-science research into timely patient benefit and sustainable economic value. Its focus on regulatory predictability, clinical trial efficiency, digitalisation, strategic project support, and improved conditions for SMEs and scale-ups is well placed.

Overall assessment The proposed European Biotech Act addresses several well-documented barriers that currently limit the EUs ability to translate strong life-science research into timely patient benefit and sustainable economic value. In particular, its focus on regulatory predictability, clinical trial efficiency, digitalisation, and support for SMEs and spin-offs is welcome.

The objective of this draft implementing regulation to harmonise notified body practices, improve predictability, and reduce unnecessary delays under Regulations (EU) 2017/745 and 2017/746 is timely and appropriate.

Aligning dataset descriptions with clinically meaningful interpretation in the EHDS The proposed implementing regulation represents an important step toward enabling interoperable dataset catalogues under the European Health Data Space.

To ensure that the European Health Data Space (EHDS) delivers its intended benefits for patients, research, and healthcare innovation, it is important that the EHDS Board includes or systematically consults stakeholders with expertise in data-driven biomedical research, diagnostics development, and patient-centred data governance.

Clinical interoperability as a complement to data interoperability in MyHealth@EU The proposed implementing regulation establishes a robust framework for the secure and interoperable cross-border exchange of personal electronic health data under MyHealth@EU.

Subject: Identity-enabled access and the need for clinically consistent data use The proposed implementing regulation establishes an important foundation for the reliable identification and authentication of natural persons, health professionals and healthcare providers in the context of cross-border exchange of electronic health data.